A week after federal legislators and hospitals pressed the Office of Management and Budget about the release of a final unique device identification rule, the U.S. Food and Drug Administration unveiled the long-awaited document, it announced this morning.
The rule, which Congress requested in 2007, hasf two components: a unique number assigned by device manufacturers to versions of models of their devices (an identifier); and a publicly searchable FDA-run database called the Global Unique Device Identification Database. The former comprise product-specific information--including a device's lot or batch number, expiration date and manufacturing date--while the latter will be a reference catalogue for all devices with those identifiers.
Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, called UDI a "landmark step" that will help to improve patient safety and fuel innovation.
"A consistent and clear way to identify medical devices will result in more reliable data on how medical devices are used," Shuren said in a statement. "In turn, this can promote safe device use by providers and patients, as well as faster, more innovative and less costly device development."
A proposed rule had been issued by the FDA in July 2012, one year after the agency originally sent a UDI proposal to OMB. Updates made last fall called for implantable devices to bear an identifier as a permanent marking one, three or five years earlier than initially proposed, depending on the class of the device, and a proposed final rule was sent to OMB in June.
In July, a range of patient advocacy groups urged OMB to publish a final rule as soon as possible. In a letter to OMB Director Sylvia Mathews Burwell, 18 groups noted that owners of recalled cars have more information than patients with dangerously defective pacemakers. Those groups included Consumers Union, Public Citizen and the National Women's Health Network.
Similar correspondence from the Advancing Patient Safety Coalition echoed a letter sent to the U.S. Food and Drug Administration in 2008.
To learn more:
- here's the final rule (.pdf)
- read the FDA announcement
- here's the Federal Register post on the rule (.pdf)
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